Hepatitis C is back in the news following Merck & Co’s $3.89 billion offer to buy Idenix Pharmaceuticals and regulators in Scotland backing the use of Gilead Sciences’ blockbuster Sovaldi for use on the NHS.
First up, Merck is paying $24.50 per share, over three times Idenix's closing price on Friday of $7.23. The latter currently has three HCV drug candidates, including the late-stage NS5A inhibitor samatasvir, although attracting most attention is the nucleotide inhibitor IDX21437, which is in Phase II.
Merck will combine the latter with its protease inhibitor MK-5172 and the NS5A inhibitor MK-8742, a closely-watched combo that has received breakthrough therapy designation from the US Food and Drug Administration. R&D chief Roger Perlmutter noted Idenix has established a promising portfolio “based on its expertise in nucleoside/nucleotide chemistry and prodrug technologies”.
He added that its HCV candidates “complement our promising therapies in development”. They will “help advance our work to develop a highly effective, once-daily, all oral, ribavirin-free, pan-genotypic regimen that has a duration of treatment as short as possible for millions of patients in need around the world”, Dr Perlmutter concluded.
The deal is being seen as quite a coup for Merck, as its offer has beaten bids from AbbVie and Johnson & Johnson, who are also looking to get a slice of the lucrative HCV pie.
SMC backs restricted use of Sovaldi
The market is very much dominated by Sovaldi (sofosbuvir) and Gilead has been boosted by the news that the Scottish Medicines Consortium has accepted its huge-selling once-daily oral nucleotide inhibitor for restricted use by NHS Scotland in combination with other HCV drugs.
Specifically, Sovaldi has been accepted for use in patients with genotypes 1 to 6, while use in treatment-naive patients with genotype 2 is restricted to those who cannot take peginterferon alfa. Also use of the 24-week interferon-free regimen of Sovaldi plus ribavirin in patients with genotype 3 is restricted again to those who are ineligible for, or are unable to tolerate, peginterferon alfa.
Gilead noted that in Scotland, since 1996, liver-related deaths among people diagnosed with HCV have increased three-fold, with deaths now outstripping those associated with HIV. Stelios Karagiannoglou, the firm’s general manager in the UK, said “we are pleased that the SMC have recognised the significant efficacy and safety profile demonstrated by sofosbuvir in clinical studies and therefore agree it is a valuable use of NHS resources”. A 12 week course of Sovaldi would cost £34,983, based on the NHS list price of £11,661 for 28 x 400mg tabs
Petra Wright, Scottish officer for the Hepatitis C Trust said that “the advent of these ‘patient friendly’ medications will reduce treatment duration and the severity of side effects”. She added that the Sovaldi thumbs-up “is a step in the right direction which we hope will hasten the elimination of HCV from Scotland”.